An observational study in Malnutrition and Obesity, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 2 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by University of Michigan Rogel Cancer Center · Observational
Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 55 is below the median of 203 across 388 observational studies indexed under Malnutrition.
Browse Malnutrition studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
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Pediatric hematopoietic cell transplant patients
Exclusion Criteria:
This is an observational study. Validated measures of nutritional status, dietary intake, body composition, functional status and psychosocial factors will be used to measure outcomes in study patients at 4 time-points: (1) pre-HCT (Baseline), (2) 30-days post-HCT, (3) 100-days post-HCT and (4) one year post-HCT.
Feasibility of comprehensive nutrition assessments in pediatric HCT patients
Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.
Time frame: 1 year post-HCT
Dietary intake
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Determination of lean body mass measured using air displacement plethysmography (BOD POD)
Time frame: baseline (pre-HCT); day 100 and 1 year post-HCT
Hand grip strength
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
PedsQL Pediatric Quality of Life Inventory
Participants 10 years or older
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
PedsQL Cognitive Functioning Scale
Participants 10 years or older
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Dietary Patient Self-Efficacy Survey
Participants 10 years or older
Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center